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Advancing prevention of sexually transmitted infections through point-of-care testing: target product profiles and landscape analysis
  1. Igor Toskin1,
  2. Maurine Murtagh2,
  3. Rosanna W Peeling3,
  4. Karel Blondeel1,4,
  5. Joanna Cordero1,
  6. James Kiarie1
  1. 1 Department of Reproductive Health and Research, World Health Organization (WHO), Geneva, Switzerland
  2. 2 The Murtagh Group, Limited Liability Company (LLC), Woodside, USA
  3. 3 London School of Hygiene and Tropical Medicine (LSHTM), London, UK
  4. 4 Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
  1. Correspondence to Dr Igor Toskin, Department of Reproductive Health and Research, World Health Organization (WHO), Geneva, Switzerland; toskini{at}who.int

Abstract

Objectives Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing.

Methods Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions.

Results The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs.

Conclusion More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low- and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence.

  • genital tract infect
  • prevention
  • public health
  • syphilis
  • testing

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Footnotes

  • Handling editor Jackie A Cassell

  • Contributors IT and MM designed the concept and methodology; IT, MM, KB, RWP and JC conducted the analysis and synthesis of the results. All authors contributed to the finalisation of the manuscript.

  • Disclaimer The authors are staff members of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the views, decisions or policies of the World Health Organization.

  • Competing interests None declared.

  • Provenance and peer review Commissioned; externally peer reviewed.

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